Identity Checks

Under clause 3.5 of the SSBA Standards an identity check must be conducted by a registered entity prior to authorising persons for the purposes listed under clause 3.3 of the SSBA Standards. If a person is required to undergo an NHS check the identity check must be completed prior to submitting the NHS check to AusCheck. It should be noted that identity checks must be undertaken even if a person holds a National Security Clearance or has been a long term employee of the entity.

The identity check must include:

Evidence of commencement of identity in Australia;

Linkage between identity and the person;

Evidence of operation in the community; and

Evidence of residential address.

A person may only need to supply one document from each of the categories a to c to satisfy the requirements of the Standards. A document from category d may only be required if proof of residential address does not form part of the documentation supplied for the previous categories.

The entity must keep a record of what documents were provided to satisfy the criteria above, however is not required to keep copies of the actual documents.

It is also recommended that identity checks be considered for approved persons, especially if they will have regular access to the facility, SSBAs held or sensitive information.

Further details about the requirements for identity checks can be found under Clause 3.5 of the SSBA Standards.

Gain of Function Research

Entities are reminded that the creation of an SSBA from an organism not previously an SSBA must be reported to the Regulatory Scheme.

To meet the criteria for being an SSBA, an agent must be infectious, viable and pathogenic, or must be an active toxin. Influenza viruses must be highly pathogenic viruses infecting humans. (Refer to the SSBA website for a list of what is considered an SSBA).

If an entity is undertaking research and during this research confers any of the above traits on a biological agent and the biological agent then meets the criteria for being an SSBA, the entity must report this to the SSBA Regulatory Scheme either as a new SSBA handling or an alteration of the purpose for handling (if not already registered for this purpose).

Easter Close

The SSBA Regulatory Scheme Team would like to wish you all a Happy and Safe Easter.

The SSBA Regulatory Scheme Helpdesk and Inbox will be unavailable over the Easter break (3-6 April 2015). The DCS will still be operational for the submission of reports during the close down period.

If you have an emergency involving SSBAs during the shutdown period, please call the National Security Hotline on 1800 123 400 or your local police.

OGTR IBC Conference

Team members from the SSBA Regulatory Scheme will be attending the Office of the Gene Technology Regulator’s Institutional Biosafety Committee Conference to be held in Canberra on 29-30 April 2015.

SSBA Team members will be available on 30 April 2015 for discussion of the Regulatory Scheme and to answer any queries.

Details of the IBC Conference can be obtained by contacting the OGTR directly - (ogtr@health.gov.au).

SSBA Officers will be at the OGTR IBC Conference on 30 April 2015

Entity and Facility Specific Training

The SSBA Regulatory Scheme has produced a new template to assist entities and facilities to meet the requirement for specific training under clause 3.9.1 of the SSBA Standards.

A PowerPoint presentation has been developed to align with the relevant clauses in the SSBA Standards that may require training on entity/facility specific policies and procedures. A section has also been included on reporting to the SSBA Regulatory Scheme.

The slides have been broken up into sections each covering one Part of the SSBA Standards and trainers are encouraged to add or remove slides as needed.

Trainers are also encouraged to consider using each section, or a small group of sections, as a separate module for training purposes to allow training to be tailored to specific audiences – for example you may wish to include different information when training laboratory staff than that provided to staff who are only accessing sensitive information (such as IT personnel.)

The use of the training template is not mandatory and entities may use other training packages if preferred.

The new training template can obtained by requesting a copy through the SSBA Inbox - (ssba@health.gov.au).

DCS Issues with Internet Explorer

Health has recently been made aware of potential issues when using Internet Explorer to access the Data Collection System (DCS).

Entities are reminded that they should keep internet browsers current as out of date browsers may not connect to or submit reports via the DCS successfully.

If issues are experienced it is recommended to first check if the DCS will operate under another browser such as Firefox or Chrome and to update browsers to the latest version.

Any continuing issues with the DCS should be reported to the SSBA Regulatory Scheme.

Updating Contact Officer Details

The Contact Officer in a non-registered facility is the person authorised to make a report on behalf of a facility.

The SSBA Regulatory Scheme will also contact this person if it has queries about the facility or a report and this person will receive notices and new passwords when the DCS password for the facility is reset.

As such, it is very important that Contact Officer details are accurate and up to date.

Use the Data Collection System (DCS) and select YES to the question Have Your Entity or Facility Details Changed, then complete the section titled Facility Contact Details (person responsible for the facility).

Results of Confirmatory Testing Reports vs Temporary Handling Reports

When should you use the Results of Confirmatory Testing section of the Report for Suspected SSBAs and Confirmatory Testing Results?

If your facility has undertaken preliminary testing that has indicated that you may have an SSBA (a suspected SSBA) and you have arranged for confirmatory testing (either in house or externally) you must report the results using the Results of Confirmatory Testing section of the Report for Suspected SSBAs and Confirmatory Testing Results.

If you have obtained these results within two business days of forming the suspicion that you are handing an SSBA, you can complete the suspected SSBA report and the outcomes of confirmatory testing report in one form.

Otherwise, you must report the suspected SSBA within two business days of forming the suspicion of handling, and then report the results of the confirmatory testing within two business days of receipt of the results.

When should you use the Temporary Handling form?

If your facility has received a known* SSBA from another facility, or if you have not done any preliminary testing but are informed by another facility that a sample you are holding contains an SSBA (for example, if you have not undertaken any testing, but have sent samples to another laboratory for testing and this laboratory then detects an SSBA), you should fill in a Temporary Handling form.

It is important to state where the sample has been obtained from in this form. If your laboratory is informed that a sample you are holding is an SSBA, you should provide information in the form under ‘Where was the SSBA received from’ about which laboratory provided you with the information that your sample contained an SSBA.

(* a known SSBA is one that was previouslyconfirmed in another facility and then transferred to your laboratory.)

More information on this topic, including flow charts on what and when to report, can be found in Guidelines 2 and 9.